Pharmacovigilance complexity and demands have been intensifying in recent years. Legislative requirements have continued to expand, with 16 good pharmacovigilance practice (GVP) modules covering all major pharmacovigilance processes for any product authorized in the European Union (EU)[1].
With regulatory requirements, market competition, and the rising cost of development intensifying, organizations are seeking new avenues to optimize efficiencies, reduce costs, and maximize profitability across the product lifecycle. This is leading many companies to shift pharmacovigilance (PV) processes to outsourcing partners, and, in some cases, to adopt an end-to-end PV outsourcing model covering all legislated requirements.
Identifying the benefits of end-to-end PV outsourcing
End-to-end PV outsourcing can, we believe, drive growth and innovation, if managed properly. Among the many benefits it can bring are:
- Strengthening internal PV teams with highly experienced global and local domain experts
- Reducing operational costs while significantly improving reporting and oversight
- Improving reporting and oversight through the use of dashboards that display key performance indicators (KPIs), providing companies with clear insight into the status of outsourced tasks
- Enabling PV leaders to focus on business-critical safety strategies
- Freeing PV teams to focus on innovation and growth
- Streamlining growth in new markets with structured global PV processes
- Avoiding risks and delays at the local level, which can occur if PV teams are unfamiliar with country-specific requirements
Following requirements with PV services
PV requirements in local markets vary, so knowledge of each country’s requirements and on-the-ground expertise is important if companies are to meet their obligations.
In the EU, GVP requirements apply to marketing authorization holders (MAHs), national competent authorities (NCAs), and the EMA. However, each member state can implement these requirements differently at the local level [1]. For example, 17 countries in the EU require companies to have local PV presence after marketing authorization has been granted – regardless of whether the product is marketed in that country or not[2].
Companies must also make sure they have a properly established and maintained pharmacovigilance system master file (PSMF), as stipulated under GVP guidelines, module II[3].
Having a European qualified person for pharmacovigilance (QPPV) and a backup for that person is a requirement for any company with products in the EU. Among the QPPV’s responsibilities are preparing and managing the PSMF and handling safety data exchange agreements (SDEA), which outline the responsibilities for collecting, evaluating, and reporting safety information[4].
In parallel with PV requirements is the need for qualified professionals to handle medical information inquiries. Here, again, having local support from pharmacists or other qualified professionals who can speak the local language is important to ensure patients’ and healthcare providers’ questions are properly addressed and any adverse events are reported.
There are also several operational activities that companies often choose to outsource to a partner, including writing aggregate reports (such as periodic safety update reports – PSURs), global literature screening, Individual Case Safety Report (ICSR) management, and benefit risk management.
In best practice situations, an outsourcing partner will advise, build, and operate all PV capabilities at a global and local level and work cross-functionally with other teams, including regulatory and quality, to provide an integrated solution.
Must-dos with full-service PV outsourcing
End-to-end PV outsourcing can be transformational, but to achieve the objectives of streamlining processes and reducing costs it is imperative that the partner a company selects operates within a well-defined and structured framework.
Among the capabilities we believe companies should be assessing are that the outsourcing partner utilizes trusted platform technologies, such as a safety database, for all reporting requirements. Another priority is proper governance of the PV system. What is the governance hierarchy of the project? What are the communication channels? Is there a single point of contact? All this should be described in the PV system governance.
Local PV services are an important element of end-to-end outsourcing for any company with products in multiple markets. Having on-the-ground experts will be crucial when dealing with local legislation and local authorities. While some countries largely follow the GVP modules with minor modifications, others have very different requirements, such as dissemination of drug safety information linked to a health insurance billing system and adverse drug event report evaluations of healthcare organizations.
This local expertise should be linked to the global PV activities to support proper oversight and continuity. Robust backup should be built into any outsourcing service to prevent any service interruption in the agreed upon time and at the expected service level.
Full-service outsourcing should cover operational support with such activities as case processing, aggregate safety reporting, management of the PSMF, reporting information from the authorities, signal management, benefit-risk management and any changes to the risk management plan.
Companies are also advised to ensure their partners can demonstrate high-quality working practices through clear and continuous KPIs that show, for example, case processing quality, data entry quality, medical judgement quality, and submission timelines. Ideally, every PV service should have its own KPIs so the quality is controlled.
Other invaluable services that a good outsourcing partner can offer include pharmacovigilance audits of third parties, corrective and preventive action (CAPA) management, and scheduling of PV audits. Carrying out mock inspections can also help companies to be inspection-ready, and outsourcing that service to a qualified partner can help ensure those mock inspections are carried out in a validated environment.
With advances in technology and the opportunity to further reduce costs, an outsourcing partner with automation and artificial intelligence capabilities can help to achieve this goal. Examples where automation can make a difference in PV include handling case intake and conducting signal detection.
Conclusion: Reducing the PV burden
While the accountability for PV remains with the marketing authorization holder, a good outsourcing partner can alleviate much of the legal burden companies face. By transferring many or even most of the tasks needed to fulfill a company’s PV responsibilities to an outsourcing partner, companies can reduce their internal PV teams and harmonize their PV processes across global markets.
In so doing, internal PV teams can focus on business-critical safety strategies, such as developing additional markets or focusing on a new drug or therapy area.
To learn more about PV outsourcing and the potential benefits, listen to PharmaLex’s on-demand Webinar — How full pharmacovigilance outsourcing increases efficiency and accuracy.
About the author:
Michael Marschler is Senior Director, Principal Consultant and Head of Pharmacovigilance Customer Success Management at PharmaLex. Michael is a pharmacist with more than 25 years of experience in pharmacovigilance. He has worked in various leading positions in the industry.
[1] Good pharmacovigilance practices (GVP), EMA. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices-gvp
[2] Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level, EMA. https://www.ema.europa.eu/en/documents/other/information-member-states-requirement-nomination-pharmacovigilance-phv-contact-person-national-level_en.pdf
[3] Guideline on good pharmacovigilance practices (GVP), Module II – Pharmacovigilance system master file (Rev 2),
[4] Guideline on good pharmacovigilance practices (GVP), Module I, EMA/HMA, June 2012. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices-module-i-pharmacovigilance-systems-and-their-quality-systems_en.pdf
